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Completed

NCT Number: NCT02016742

A Phase 1 Study of the Pharmacokinetics of RDC5 in Healthy Volunteers

The purpose of this study is to characterise the pharmacokinetics, safety and tolerability of RDC5 given as a single dose to healthy volunteers at a number of different dose levels

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Simbec Research Ltd

Merthyr Tydfil, CF48 4DR, United Kingdom

About this study

This is an open-label, randomised, single dose, 3-way crossover study to characterise and compare the PK, safety and tolerability of RDC5 in 15 healthy male volunteers. Eligible subjects will undergo 3 Treatment Periods, each separated by a washout period at least 14 days. Subjects will receive a single dose of RDC5 during each of the three Treatment Periods in line with their randomized treatment sequence. A total of 4 dose levels will be evaluated within the study, though each subject will only receive 3 doses. A Data Review Team (DRT) will review the pharmacokinetic (PK) data from Treatment Periods 1 and 2 and select the doses to be evaluated in Treatment Periods 2 and 3. Subjects will return for a follow visit 21 days after the last dose of RDC5.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to use effective method of contraception
  • Non smoker or ex-smoker within the previous 6 months

Exclusion criteria

  • History or presence of any clinically significant findings upon screening
  • Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days
  • Positive result for human immunodeficiency virus (HIV) and/or hepatitis B or C test
  • Positive result for urine alcohol and drug screen
  • Blood donation ≥ 450 mL in the previous 12 weeks
  • Receipt of prescription medicines and/or St John's Wort in the previous 2 weeks

Treatment and study plan

RDC5

Drug

Primary outcomes

  1. Area under the concentration-time curve from time 0 to infinity (AUC0-inf) for the whole blood concentration of RDC5

    Time frame: Up to 6 days post dose

Secondary outcomes

  1. AUC from time 0 to time of last observed concentration (AUC0-t)

    Time frame: Up to 6 days post dose

  2. Maximum observed concentration (Cmax)

    Time frame: Up to 6 days post dose

  3. Time at which Cmax occurred (tmax)

    Time frame: Up to 6 days post dose

  4. Elimination half-life (t1/2)

    Time frame: Up to 6 days post dose

  5. Terminal phase elimination rate constant (λz)

    Time frame: Up to 6 days post dose

  6. Apparent volume of distribution (Vd/F)

    Time frame: Up to 6 days post dose

  7. Apparent oral clearance (CL/F)

    Time frame: Up to 6 days post dose

  8. Number (%) healthy volunteers with treatment emergent adverse events (AEs)

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Chronos Therapeutics Ltd

Industry

Registry information

Official study title

A Phase I, Open-label, Randomised, 3-way Crossover Study to Characterise and Compare the Pharmacokinetics, Safety and Tolerability of RDC5 Given as a Single Dose to Healthy Volunteers

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 20, 2013
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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